Biocon Biologics clears path for U.S. launch of denosumab biosimilars Bosaya and Aukelso
Settlement with Amgen enables commercialisation of Bosaya and Aukelso in the United States from October 1, 2025
Biocon Biologics, a global biosimilars company and subsidiary of Biocon, announced a settlement and licence agreement with Amgen that allows the commercialisation of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the United States.
Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL injection for subcutaneous use in a single-dose vial) are biosimilars to Amgen’s Prolia and Xgeva, respectively. The products are used in the treatment of osteoporosis and cancer-related bone conditions.
The settlement resolves pending patent litigation at the United States District Court for the District of New Jersey and allows Biocon Biologics to launch Bosaya and Aukelso in the U.S. from 1 October 2025. Other terms of the settlement remain confidential.
Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “This settlement paves the way for Biocon Biologics to bring our high-quality denosumab biosimilars, Aukelso and Bosaya, to patients and healthcare providers in the United States. These therapies will not only strengthen our oncology portfolio but also mark our entry into the bone health space—an important step as we continue to broaden access to life-changing biologics for patients across therapeutic areas. By expanding access to advanced biologic medicines, we are reaffirming our role as a global biosimilar leader.”
The U.S. Food and Drug Administration (FDA) approved Bosaya and Aukelso in September 2025 and granted provisional interchangeability designation for both products.
Bosaya is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Aukelso is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours, to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.
Clinical data indicated that both biosimilars demonstrated comparable quality, safety, and efficacy to the reference products. Bosaya is approved with the same Risk Evaluation and Mitigation Strategy (REMS) plan as Prolia, informing healthcare providers and patients of the risks of severe hypocalcaemia in patients with advanced conditions.